IMAT Quality in Aging

NCT07506681 | Not Yet Recruiting DMC

• 2 other identifiers: 2025120461R21AG091159-01A1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the central hypothesis that fat within the muscle, or intramuscular adipose tissue (IMAT), exhibits elevated damage and pro-inflammatory signaling with aging, both of which are reduced by progressive resistance exercise (PRE). Sixteen older adults 65-80 years old will be recruited and complete a 12 week calf PRE intervention. Calf muscle strength, composition (measured by computed tomography) and muscle biopsies will be collected before and after the intervention. Histology, transcriptomic and secretomic tests will be completed to assess signs of damage and inflammation.

Conditions

Aging

Keywords

aging; muscle

Outcome Measures

Primary Outcomes (1)

• Biopsy: Senescent cell density

  Senescent cells will be identified by expression of β-galactosidase (b-gal) and p16 on histological sections from muscle biopsies. B-gal and p16 positive cells will be counted and normalized to the histological region of interest to obtain a measure of density (# senescent cells / mm\^2).

  Baseline and post-intervention (approximately 14 weeks after baseline)

Secondary Outcomes (12)

• Total plantarflexor muscle volume (CT) (Cm^3)

  Baseline and post-intervention (approximately 14 weeks after baseline)

• Plantarflexor Compartment Intramuscular Fat Volume (cm^3)

  Baseline and post-intervention (approximately 14 weeks after baseline)

• Plantarflexor peak torque (Newton-meters)

  Baseline and post-intervention (approximately 14 weeks after baseline)

• Stair Climb Power (W)

  Baseline and post-intervention (approximately 14 weeks after baseline)

• Walking Speed (meters/second)

  Baseline and post-intervention (approximately 14 weeks after baseline)

Study Arms (1)

Calf muscle strengthening

EXPERIMENTAL

Older adults will complete a 3x/wk, 12 week calf strengthening exercise over zoom. The intervention will be delivered in small groups. Older adult baseline data will be compared to post-intervention data to understand the impact of exercise on aging muscle and fat within the muscle

Other: Calf muscle strengthening

Interventions

Calf muscle strengthening OTHER

The calf intervention will be delivered 3x/wk for 12 weeks over zoom, in small groups. There are 3 exercises 1) standing heel rise, 2) seated heel rise, and 3) long sitting ankle plantarflexion. The exercises will be overloaded using a weighted vest, body weight, and/or theraband. Exercises will be progressed as strength improves.

Calf muscle strengthening

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Rapid Assessment of Physical Activity scores between 3 and 5
• Able to don and doff the weighted vest
• Access to a smart phone and ability to navigate the phone to enter and manage a zoom intervention
• Commitment and availability to attend a virtual 40-minute intervention 3x per week for 12 weeks

You may not qualify if:

• Contraindications to radiation exposure (e.g. Women who are pregnant, previous high radiation exposure)
• Bleeding disorders
• Lower extremity trauma/surgery/injury or neuropathy that would impact muscle structure and function or ability to complete exercise intervention
• Diabetes mellitus, cardiovascular disease, peripheral vascular disease, cancer, stage 4 hypertension, anemia, connective tissue disorder
• Neurological disorder (e.g. stroke, Parkinson's disease, multiple sclerosis, spinal cord injury)
• Medications: insulin, glucagon-like peptide-1 (GLP1) agonists, sex hormone replacement therapy, chronic NSAIDs, anticoagulation therapy, cholesterol lowering medications such as statins
• Unable to safely perform the progressive resistance exercise (e.g. Vestibular or balance issues that make performing the intervention unsafe, severe osteoporosis or general fragility that limits weighted vest tolerance)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Washington University

St Louis, Missouri, 63108, United States

Location

Study Officials

• Gretchen Meyer, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Hastings, PT, DPT, MSCI, ATC

CONTACT

1 314-286-1433; hastingsmk@wustl.edu

Gretchen Meyer, PhD

CONTACT

1-314-286-1456; meyerg@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Older adults (65-80 years old) will complete pre and post intervention testing.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: April 2, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared as soon as possible and no later than the time of publication or at the end of the funding period, whichever comes first
• Access Criteria: All shared data will be de-identified and accessible in a controlled manner according to the guidance of Washington University's Human Research Protection Office (HRPO).

Locations

US (1)